ISRCTN73814534已完成不适用
A phase I and randomised phase II study of docetaxel and RAD001 (Everolimus) in advanced / recurrent or metastatic squamous cell carcinoma of the head and neck
niversity College London (UCL) (UK)0 个研究点目标入组 120 人开始时间: 2007年7月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Locally advanced or metastatic squamous cell carcinoma of the head and neck (histologically proven)
- •2. Estimated life expectancy of at least 12 weeks
- •3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •4. Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) criteria (NB: For the purposes of this study recurrent disease within a previous radiation field can be considered to be measurable)
- •5. Aged 18 years or over
- •6. Patient willing and able to give written informed consent
- •7. Haematological parameters within a week prior to study entry: -
- •7.1. Blood cell counts:
- •a. Absolute neutrophils greater than or equal to 1.5 x 10^9/L
- •b. Platelets greater than or equal to 100 x 10^9/L
- •c. Haemoglobin greater than or equal to 10 g/dl
- •7.2. Renal function:
- •a. Urea and creatinine within normal limits
- •7.3. Hepatic functions:
- •a. Serum bilirubin within normal limits
- •b. AST or ALT <1.5 x ULN with alkaline phosphatase <2.5 x ULN
- •8. Patients may have received one line of prior chemotherapy for locally advanced or metastatic disease (but not a taxane)
- •9. Patients may have received prior radiation therapy for locally advanced or metastatic disease (but must have completed the radiotherapy more than six months before recruitment)
- •10. Female patients potentially able to child bear should have a negative pregnancy test prior to commencing the study drugs, and agree to use an approved contraceptive method (Intrauterine Device [IUD], birth control pills or barrier device) during and for 3 months after the last dose of the study drugs. All male patients should take adequate contraceptive precautions during and up to 2 months after the last dose of the study drugs
排除标准
- •1. Potentially curable disease
- •2. Disease relapsed within 6 months of radiotherapy
- •3. Patients with locally advanced disease for whom radiotherapy is indicated
- •4. Previous chemotherapy for any cancer, except for head and neck cancer
- •5. Previous chemotherapy with a taxane
- •6. Previous therapy with any erbB inhibitors (except Cetuximab given with radiotherapy, as indicated in treatment algorithm)
- •7. Treatment within the last 4 weeks with any investigational drug
- •8. The current use of drugs which are known to inhibit CYP3A4 (except dexamethasone), or block P-glycoprotein, including grapefruit juice
- •9. Evidence of the presence of central nervous system metastases
- •10. Evidence of uncontrolled infection
- •11. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
- •12. History of hypersensitivity to docetaxel or any of its excipients
- •13. Pregnant or breast-feeding
研究者
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